Tricuspid Regurgitation (TR)
Conditions
Keywords
Tricuspid Regurgitation, Transvenous Tricuspid Replacement, LuX-Valve Plus System
Brief summary
The goal of this clinical trial is to learn if LuX-Valve Plus system works to treat symptomatic subjects with at least severe tricuspid regurgitation (TR). It will also learn about the safety of LuX-Valve Plus system. Researchers will compare LuX-Valve Plus system to a conventional device called EVOQUE to see if LuX-Valve Plus system works to treat subjects with at least severe tricuspid regurgitation. Participants will: Undergo one procedure using the LuX-Valve Plus system or EVOQUE after passing screening and enrolling in the trial; Complete follow-up visits and examinations as required by the trial protocol; Report any adverse events
Interventions
DEVICETTVI with LuX-Valve Plus System
Transvenous tricuspid valve replacement with Lux-Valve Plus System in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)
DEVICETTVI with EVOQUE
Transvenous tricuspid valve replacement with EVOQUE in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)
Sponsors
Jenscare Innovation Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical Events Committee
Intervention model description
The study will consist of two cohorts. 1. EVOQUE Eligible Cohort: 400 subjects randomized 2:1 (LuX-Valve:EVOQUE) will be used to demonstrate that the LuX-Valve is noninferior to EVOQUE. These subjects will have met ALL the following requirements: * Met the inclusions/exclusion criteria, * Deemed a transcatheter candidate by the heart team, * Eligible for an EVOQUE device based on commercial sponsor assessment. 2. "Not Suitable for Conventional TTVI"cohort": A single arm study of 180 subjects will be used to demonstrate Lux meets a pre-specified performance goal. These subjects will have met ALL the following requirements: * Meets all inclusions/exclusion criteria. * Deemed suitable for transcatheter candidates by the heart team. * Deemed suitable for the LuX-Valve. * Deemed not suitable for an EVOQUE device based on commercial sponsor assessment. * Deemed not suitable for T-TEER based on echocardiographic assessment of two independent structural cardiologists
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For the randomized study: 1. Subject is at least 21 years of age at time of consent. 2. Subject (or legal guardian) understands trial requirements and treatment procedures and is able to provide written informed consent. 3. Severe or greater TR as assessed on transthoracic echocardiography by core lab. 4. New York Heart Association (NYHA) Class II-IV. 5. On optimal medical therapy (OMT) for TR at the time of baseline assessment per site Heart Team. OMT includes stable oral diuretic medications unless patient has a documented history of intolerance. 6. The site Heart Team concurs that the patient is a good candidate for transcatheter tricuspid valve replacement and suitable for LuX-Valve Plus system by core lab. 7. The commercial sponsor for EVOQUE deems that the patient is a good candidate for EVOQUE valve (control arm). For single arm cohort ("Not Suitable for Conventional TTVI") 1. Meets all criteria 1-6 above 2. The EVOQUE commercial sponsor deems the anatomy unsuitable for EVOQUE tricuspid valve replacement, or the annular perimeter is smaller or greaterthan EVOQUE commercial Instructions for Use (IFU), as determined by the clinical site 3. Two independent Structural Cardiologists determine the patient "Not Suitable" for Transcatheter edge to edge repair
Exclusion criteria
1. Left ventricular ejection fraction (LVEF) \<35%. 2. Pulmonary arterial systolic pressure (PASP) \>60 mmHg by echo Doppler (unless right heart catheterization \[RHC\] demonstrates PASP ≤60mmHg); in case RHC is performed, PASP \>2/3 systemic BP with PVR \>5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP \<90 mmHg. 3. Evidence of intracardiac mass, thrombus, or vegetation. 4. Ebstein Anomaly or congenital right ventricular dysplasia. 5. Surgical or interventional correction is indicated for other concomitant valvular diseases (subjects with concomitant valvular disease may treat their respective valve first and wait 30 days before being reassessed for the trial). 6. Subjects with valve prostheses implanted in the tricuspid valve. 7. Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction. 8. Active infection, infective endocarditis or sepsis within 3 months, or infections requiring antibiotics treatment within two weeks prior to planned procedure. 9. Untreated clinically significant coronary artery disease requiring revascularization. 10. Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure. 11. Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure. 12. Cerebrovascular stroke (ischemic or bleeding) within 3 months prior to enrollment. 13. Active peptic ulcer or active gastrointestinal bleeding within 3 months prior to enrollment. 14. Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis, or coagulopathy. 15. Inability to tolerate anticoagulation or antiplatelet therapy. 16. Renal insufficiency (eGFR\< 30ml/min \[per the CKD-EPI formula\] and/or renal replacement therapy). 17. Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C 18. Pregnancy or intent to become pregnant. 19. Severe Chronic Obstructive Pulmonary Disease requiring steroids or requiring continuous home oxygen. 20. Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media. 21. Estimated life expectancy \<12 months. 22. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint. 23. Subjects with current history of illicit drug use. 24. Any other condition making it unlikely the patient will be able to complete all protocol procedure and follow-ups determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Events (MAE) | 30 Day Post-Procedure | Rate of Major Adverse Events (MAE) at 30 days consisting of the following components: * Cardiovascular Mortality * Myocardial Infarction (MI), periprocedural and spontaneous * All Stroke, disabling and non-disabling * New need for renal replacement therapy * Severe bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\] * Non-elective tricuspid valve re-intervention, surgery or transcatheter * Major access site and vascular complications * Major cardiac structural complications * Device-related pulmonary embolism * Arrhythmia and conduction disorders requiring permanent pacing |
| Rate of Composite Clinical Success | 12 Months Post-Procedure | Percentage (%) of participants achieving composite clinical success at 12 months. Composite clinical success is defined as meeting all of the following criteria: Patient survival, Free from heart failure hospitalization, No tricuspid valve surgery or percutaneous intervention |
Countries
Canada, United States
Contacts
CONTACTChen Jiao, MD
Outcome results
None listed